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Published on: March 6, 2018
Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer
Cora N Sternberg1, Karim Fizazi1, Fred Saad1
1From the Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); the University of Paris Saclay, Villejuif, France (K.F.); the University of Montreal Hospital Center, Montreal (F.S.), and Cross Cancer Institute, University of Alberta, Edmonton (M.P.K.) - both in Canada; the Carolina Urologic Research Center, Myrtle Beach, SC (N.D.S.); Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy (U.D.); Vanderbilt University, Nashville (D.F.P.); the State University of Campinas (Unicamp), Campinas (U.F.), and the ABC Foundation School of Medicine, Santo André (D.I.G.C.) - both in Brazil; M.D. Anderson Cancer Center, Houston (E.E.); Wroclaw Medical University, Wroclaw, Poland (K. Madziarska); Sygehus Lillebælt, Vejle, Denmark (B.N.); Pfizer, La Jolla (F.Z., X.L.), and Pfizer, San Francisco (K. Modelska) - both in California; and Astellas Pharma, Northbrook (J. Sugg, J. Steinberg), and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago (M.H.) - both in Illinois.
Enzalutamide significantly improved overall survival in men with nonmetastatic, castration-resistant prostate cancer. This treatment reduced the risk of death by 27% compared to placebo, with manageable side effects.
Area of Science:
- Oncology
- Urology
- Clinical Trials
Background:
- Nonmetastatic, castration-resistant prostate cancer (CRPC) with rising PSA is a critical clinical challenge.
- Androgen-deprivation therapy (ADT) is a standard treatment, but novel therapies are needed.
- Enzalutamide has shown promise in improving outcomes for prostate cancer patients.
Purpose of the Study:
- To evaluate the efficacy and safety of enzalutamide plus ADT versus placebo plus ADT in men with nonmetastatic CRPC.
- To assess the impact of enzalutamide on overall survival (OS) in this patient population.
- To determine the safety profile of enzalutamide in combination with ADT.
Main Methods:
- A double-blind, phase 3 randomized controlled trial (PROSPER) was conducted.
- Men with nonmetastatic CRPC and PSA doubling time ≤10 months received enzalutamide (160 mg/day) or placebo, alongside ADT.
- Overall survival was the primary endpoint, assessed using group sequential methods.
Main Results:
- Median OS was significantly longer in the enzalutamide group (67.0 months) compared to the placebo group (56.3 months).
- Enzalutamide demonstrated a 27% reduction in the risk of death (hazard ratio, 0.73; P=0.001).
- Adverse events were consistent with enzalutamide's known safety profile, with fatigue and musculoskeletal events being most common.
Conclusions:
- Enzalutamide plus ADT significantly improves overall survival in men with nonmetastatic CRPC and a rapidly rising PSA.
- The safety profile of enzalutamide in this trial is consistent with previous findings.
- Enzalutamide represents an effective treatment option for this specific patient group.
